Eliquis (apixaban) gained approval to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the U.S., the 27 countries in the European Union, Canada, and Japan, and is under review in other countries. Eliquis, an oral Factor Xa inhibitor anticoagulant, has demonstrated superior risk reductions versus warfarin in three key outcomes of stroke and systemic embolism, major bleeding and all-cause death in patients with nonvalvular atrial fibrillation. In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize this oral anticoagulant, which was discovered by Bristol-Myers Squibb.

Lyrica (pregabalin) capsules CV received a new indication in the U.S. for the management of neuropathic pain associated with spinal cord injury. This is the fifth indication approved for Lyrica. Core indications for Lyrica are fibromyalgia and diabetic peripheral neuropathy, and Lyrica is the first indication approved for the management of neuropathic pain associated with spinal cord injury in the U.S.

Lyrica received regulatory approval in Japan for the additional indication of pain associated with fibromyalgia.

Integrated Health, Pfizer's new approach to identifying innovative ways to partner with payers, providers and employers to improve patient outcomes, launched its first two products focused on the employer health and wellness market: KEAS, an online platform designed to engage employees around healthy behaviors; and the American Health Strategies Project, a tool designed to help demonstrate the costs of chronic diseases and highlight potential interventions to reduce costs and improve employee health outcomes.

The U.S. Food and Drug Administration approved Xeljanz (tofacitinib) 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Prevenar 13 received regulatory approvals for the adult indication in more than 80 countries.

Initiated the first Phase III study for our investigational vaccine, rLP2086, part of the largest vaccine clinical development program to date in invasive meningococcal B disease.

Initiated Phase III studies for tofacitinib in ulcerative colitis.

Launched Vyndaqel (tafamidis) in seven countries in the EU, including Portugal, Germany, Austria, Luxembourg and Sweden.

Launched BeneFIX (coagulation factor IX (recombinant)) 3000 IU dosage and new Xyntha (antihemophilic factor (recombinant), plasma/albumin-free) dosage sizes.

Celebrated anniversaries: 15 years for BeneFIX (coagulation factor IX (recombinant)); 10 years for Rebif (interferon beta1a) and the MS Lifelines Support Center.

In January 2012, Inlyta (axitinab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy. Inlyta also was approved this year in the European Union and a number of countries including Japan, Switzerland, Canada, Australia and Korea.

In September 2012, Bosulif (bosutinib) became the third new medicine from our Oncology pipeline to be approved by the U.S. FDA in 13 months, and the first therapy in Pfizer's growing hematology portfolio to receive FDA approval.

Xalkori (crizotinib) was selected as a finalist in the 2012 Most Innovative Product of the year award competition, chosen by a group of industry experts. The pivotal Phase III PROFILE 1007 data, presented at the European Society for Medical Oncology, demonstrated that Xalkori is superior to standard chemotherapy in prolonging progression free survival in patients with previously-treated ALK-positive advanced non-small cell lung cancer (NSCLC). These data established Xalkori as a standard of care for this patient population. Xalkori also has received conditional marketing authorization in the EU for the treatment of adults with previously-treated ALK-positive advanced NSCLC.

Pfizer has acquired NextWave Pharmaceuticals, a privately held, specialty pharmaceutical company focused on the development and commercialization of products for the treatment of attention deficit/hyperactivity disorder (ADHD) and related central nervous system disorders. NextWave is the developer of Quillivant XR (methylphenidate HCl) for extended-release oral suspension, CII, the first once-daily liquid medication approved in the U.S. for the treatment of ADHD, and holds exclusive North American commercialization rights to Quillivant XR. This recently approved medicine was launched in the U.S. in early 2013.

We launched Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. Elelyso is the first FDA-approved plant cell-based ERT for Gaucher disease.

Pfizer has established an exclusive long-term strategic collaboration with Mylan to develop, manufacture, distribute and market generic drugs in Japan, the second largest pharmaceutical market in the world, where there is an ever-growing demand for high quality generics.

Pfizer has created a Loss Of Exclusivity (LOE) Center of Excellence within the Established Products Business Unit to offer brand teams that are facing similar LOEs the expertise to successfully navigate brand patent expirations. The Center offers an “LOE Roadmap,” a detailed handbook for teams that are developing strategies to maximize the value of their products both before and after patent loss, and an LOE Library, which contains examples of strategic planning documents, market research and promotional materials.

We continued to outpace global OTC growth in 2012.

Through our acquisition of Ferrosan, we expanded our product offerings in the fast-growing probiotics and Omega-3 categories, and extended our geographic footprint into the Nordic markets, Russia and other Eastern European markets.

Through the acquisition of Alacer, we added a leading vitamin C supplement, Emergen-C, to our dietary supplements portfolio.

Another major business development in 2012 was the acquisition from AstraZeneca of exclusive, global over-the-counter marketing rights for Nexium. Nexium is the fifth-best selling prescription medicine and a leading prescription remedy to treat the symptoms of gastroesophageal reflux disease (GERD). The gastrointestinal health market is the fourth-largest OTC category.

Advil maintained its market-leading position in a number of key geographies, including the U.S. and Canada, with sustained revenue growth for the year.

We expanded the Centrum franchise through the accelerated launches of Centrum Gender and Centrum Cardio/Centrum Control into many markets across Europe and Latin America.